Job Description - Senior Specialist, Quality Assurance Auditor (2506229625W)
Senior Specialist, Quality Assurance Auditor - 2506229625W Purpose: In R&D Quality, we continue to invest in our talent, diversity, and expertise, to make quality a business differentiator and competitive advantage – allowing our business partners to better deliver what really matters to customers and patients.
QA delivers innovative risk-based audit and quality control approaches that provide relevant insights to proactively secure compliance and drive sustainability and reliability across Johnson & Johnson Innovative Medicine.
You will be responsible for: Leads the planning, conduct and reporting of GCP QA routine audits and supports non-routine GCP audits including Clinical Investigator Site audits, Trial/Program audits, External Service Provider audits, Process/System audits, Local Operating Country audits, to assure adherence to corporate policies, internal standards/requirements and compliance with applicable regulatory requirements.
Non-routine audits include Due Diligence, for cause audits, cross-functional, complex/sensitive system/service provider audits as defined by the scope.Ensures the relevant standard procedures, audit tools, and audit plans are fully understood and applied in audit activities.Analyzes, interprets data and identifies patterns and trends in data sets.Ensures timely and appropriate review & delivery of CAPAs and actions arising from audits.Presents information logically and concisely, both verbally and in writing, including writing reports with clarity.Provides GCP Audit strategy support, especially on QA risk-based auditing approach (Audit plans).Supports regulatory inspections in various supporting roles.Completes assigned training requirements in a timely manner to ensure inspection readiness at all times.May assist in the preparation of training material if requested.Participates in projects or serves on teams, as assigned by supervisor.Meets priorities, checkpoints, and timelines for all aspects of work and projects to achieve adequate progress.Qualifications: A minimum of a Bachelor's degree is required.
Advanced degree in scientific, medical or related subject area is preferred.A minimum of 4 years of related work experience.Knowledge of the drug development process, applicable regulations, R&D practices, and scientific and quality terminology.Knowledge of Good Clinical Practices (GCP) and applicable regulations/guidelines (e.g.
FDA regulations, EU CTR, ICH E6 R2).Understanding of fundamentals of clinical trial risk management.Broad knowledge of management of standard operating procedures, good documentation practices, and records management.Digital literacy & Analytics - Experience using standard applications/systems & data analytics tools.Ability to plan and prioritize work in an efficient manner, and to work well under time constraints.Flexibility to respond to changing business needs.Familiarity with new and emerging technologies and analytics, and the ability to see opportunities where creative capabilities may be applied within QA audit processes.Experience conducting Clinical Quality Assurance audits.Ability to interpret global regulatory standards.Inspection support experience (FDA, EMA and other inspectorates).Strong networking and relationship building skills.Experience balancing multiple projects simultaneously.Must be able to speak and write in English.This position may require up to a 25% of domestic and/or international travel.Primary LocationOther LocationsJohnson & Johnson is an Affirmative Action and Equal Opportunity Employer.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.
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